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Aortic StenosisNCT02628899

Feasibility of Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic, Severe Aortic Stenosis

A study testing Transfemoral TAVR and SAVR in people with Aortic Stenosis, run by Medstar Health Research Institute at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

To assess the safety and feasibility of Transcatheter Aortic Valve Replacement (TAVR) with commercially available bioprostheses in patients with severe, symptomatic aortic stenosis (AS) who are low-risk (STS score ≤3%) for surgical aortic valve replacement (SAVR). Read more about this study

Who is it for?
Any age
Conditions the study is for
Aortic Stenosis
What is being tested?
Transfemoral TAVR and SAVR
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
277 participants
Where
11 sitesUnited States
Study dates
Jan 2016to Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Severe, degenerative AS, defined as:
  • mean aortic valve gradient ≥40 mm Hg OR Vmax ≥4 m/sec AND
  • calculated aortic valve area ≤1.0 cm2 OR aortic valve area index ≤0.6 cm2/m2
  • Symptomatic AS, defined as a history of at least one of the following:
  • dyspnea that qualifies at New York Heart Association (NYHA) class II or greater
  • angina pectoris
Show all 14Show fewer
  • cardiac syncope
  • The Heart Team, including at least one cardiothoracic surgeon and one interventional cardiologist, deem the patient to be reasonable for transfemoral TAVR with a commercially available bioprosthetic valve
  • The Heart Team agrees that the patient is low-risk, quantified by an estimated risk of ≤3% by the calculated STS score for operative mortality at 30 days; AND agrees that SAVR would be an appropriate therapy if offered.
  • The Heart Team agrees that transfemoral TAVR is anatomically feasible, based upon multislice CT measurements
  • Procedure status is elective
  • Expected survival is at least 24 months
  • For the bicuspid cohort only:
  • Aortic Stenosis of a bicuspid aortic valve

Who cannot join

  • Concomitant disease of another heart valve or the aorta that requires either transcatheter or surgical intervention
  • Any condition that is considered a contraindication for placement of a bioprosthetic aortic valve (e.g. patient requires a mechanical aortic valve)
  • Aortic stenosis secondary to a bicuspid aortic valve (except for the bicuspid valve cohort)
  • Prior bioprosthetic surgical aortic valve replacement
  • Mechanical heart valve in another position
  • End-stage renal disease requiring hemodialysis or peritoneal dialysis, or a creatinine clearance <20 cc/min
Show all 28Show fewer
  • Left ventricular ejection fraction <20%
  • Recent (<6 months) history of stroke or transient ischemic attack
  • Symptomatic carotid or vertebral artery disease, or recent (<6 weeks) surgical or endovascular treatment of carotid stenosis
  • Any contraindication to oral antiplatelet or anticoagulation therapy following the procedure, including recent or ongoing bleeding, or HASBLED score >3
  • Severe coronary artery disease that is unrevascularized
  • Recent (<30 days) acute myocardial infarction
  • Patient cannot undergo transfemoral TAVR for anatomic reasons (as determined by supplemental imaging studies); this would include inadequate size of iliofemoral access vessels or an aortic annulus size that is not accommodated by the commercially available valves
  • Any comorbidity not captured by the STS score that would make SAVR high risk, as determined by a cardiothoracic surgeon who is a member of the heart team; this includes:
  • porcelain or severely atherosclerotic aorta
  • frailty
  • hostile chest
  • IMA or other conduit either crosses midline of sternum or is adherent to sternum
  • severe pulmonary hypertension (PA systolic pressure > 2/3 of systemic pressure)
  • severe right ventricular dysfunction
  • Ongoing sepsis or infective endocarditis
  • Recent (<30 days) or ongoing bleeding that would preclude treatment with anticoagulant or antiplatelet therapy, including recent gastrointestinal bleeding
  • Uncontrolled atrial fibrillation (resting heart rate >120 beats per minute)
  • Severe chronic obstructive pulmonary disease, as demonstrated by forced expiratory volume (FEV1) <750 cc
  • Liver failure with Childs class C or D
  • Pre-procedure shock, inotropes, mechanical assist device, or cardiac arrest
  • Pregnancy or intent to become pregnant prior to completion of all protocol follow-up procedures
  • Known allergy to warfarin or aspirin

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • WellStar Kennestone Hospital

    Marietta, Georgia, 30060

  • Maine Medical Center

    Portland, Maine, 04102

  • Miriam Hospital

    Providence, Rhode Island, 02906

  • Henrico Doctors' Hospital

    Richmond, Virginia, 23229

  • VCU Medical Center

    Richmond, Virginia, 23298

  • The Valley Hospital

    Ridgewood, New Jersey, 07450

  • Sutter Health System

    Sacramento, California, 95816

  • Foundation for Cardiovascular Medicine

    San Diego, California, 92121

  • Stony Brook Hospital

    Stony Brook, New York, 11794

  • St. John Health System

    Tulsa, Oklahoma, 74104

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

To assess the safety and feasibility of Transcatheter Aortic Valve Replacement (TAVR) with commercially available bioprostheses in patients with severe, symptomatic aortic stenosis (AS) who are low-risk (STS score ≤3%) for surgical aortic valve replacement (SAVR).

Read the detailed description

Trial Objectives: To assess the safety and feasibility of Transcatheter Aortic Valve Replacement (TAVR) with commercially available bioprostheses in patients with severe, symptomatic aortic stenosis (AS) who are low-risk (STS score ≤3%) for surgical aortic valve replacement (SAVR).

Methodology: This is a multicenter, prospective trial of TAVR in low-risk patients at up to twelve sites in the United States. The trial will have three arms. The first will comprise 200 patients undergoing transfemoral TAVR. The second arm will comprise200 closely matched historical controls who underwent isolated bioprosthetic SAVR.

Historical controls will be selected from among patients at the same site who have undergone isolated bioprosthetic SAVR within the previous 36 months. TAVR patients will then be matched to SAVR patients using STS database variables to perform propensity matching, including (but not limited to) age, gender, race, ethnicity, STS score, and valve prosthesis size. Once the historical matched controls are identified, detailed chart review will abstract in-hospital and 30-day outcomes for the SAVR cohort.

The third arm of the trial will comprise a registry of TAVR in up to 100 low-risk patients with bicuspid aortic valve. The results from the registry arm will be analyzed independently.

Primary Efficacy Endpoint: All-cause mortality at 30 days following transfemoral TAVR vs. bioprosthetic SAVR.

Primary Safety Endpoint: Defined as the composite of major adverse events at 30 days:

  1. all-cause mortality c. spontaneous myocardial infarction (MI) d. reintervention: defined as any cardiac surgery or percutaneous reintervention that repairs, alters, or replaces a previously implanted aortic valve e. VARC life-threatening bleeding f. Increase in serum creatinine to ≥300% (>3x increase compared to baseline) OR serum creatinine ≥4.0 mg/dL with an acute increase ≥0.5 mg/dL OR new requirement for dialysis g. coronary artery obstruction requiring percutaneous or surgical intervention h. VARC major vascular complication i. cardiac tamponade j. cardiac perforation k. pericarditis l. mediastinitis m. hemolysis n. infective endocarditis o. moderate or severe aortic insufficiency p. significant aortic stenosis q. permanent pacemaker implantation r. new-onset atrial fibrillation

Secondary Endpoints (TAVR Cohort):

  1. Major adverse cardiovascular and cerebrovascular events (MACCE) at 30 days, 6 months, 12 months, and 2, 3, 4 and 5 years, defined as the composite of:
  2. all-cause mortality
  3. stroke
  4. spontaneous MI
  5. reintervention
  6. The occurrence of the individual components of MACCE at 30 days, 6 months, 12 months, and 2, 3, 4, and 5 years (including stoke).
  7. The composite of major adverse device events post-procedure, and at 6 months, 1 year, and 2, 3, 4, 5 years
  8. VARC major vascular complications, at 30 days and 1 year
  9. VARC life-threatening or disabling bleeding, at 30 days and 1 year
  10. Technical success upon exit from the operating room or catheterization laboratory, defined as all of the following:
  11. alive
  12. successful access, delivery, and retrieval of the device and/or delivery system
  13. correct positioning and successful deployment of the valve
  14. no need for unplanned or emergency surgery or reintervention related to the device or access procedure, including reinstitution of cardiopulmonary bypass post-weaning for SAVR patients
  15. Device success at 30 days and 1 year, defined as all of the following:
  16. absence of procedural mortality
  17. correct positioning of a single prosthetic heart valve in the proper anatomical location
  18. device performing as intended:
  19. No migration, erosion, embolization, detachment, fracture, hemolysis requiring transfusion, thrombosis, or endocarditis 2. Intended performance of the heart valve: no prosthesis-patient mismatch, mean aortic valve gradient <20 mm Hg OR peak velocity <3 m/s, AND no moderate or severe bioprosthetic valve regurgitation 8. Procedural success at 30 days, defined as device success AND no major adverse device events 9. Bioprosthetic valve regurgitation, defined as either moderate or severe aortic regurgitation OR moderate or severe paravalvular leak, at hospital discharge, 12 months, and 2, 3, 4, and 5 years 10. Incidence of new-onset atrial fibrillation at hospital discharge, and at 30 days, 12 months, and 2, 3, 4, and 5 years.
  20. Conduction disturbance requiring permanent pacemaker implantation at hospital discharge, 12 months, and 2, 3, 4, and 5 years.
  21. Change in NYHA class from baseline to 30 days, baseline to 6 months, baseline to 12 months, and baseline to 2-5 years.
  22. Change in distance walked during 6-minute walk test from baseline to 12 months.
  23. Change in responses to the short form Kansas City Cardiomyopathy Questionnaire (KCCQ-12) from baseline to 12 months.
  24. Echocardiographic assessment of the bioprosthetic valve post-procedure, at 12 months, and at years 2-5, including (but not limited to):
  25. aortic valve mean gradient, maximum gradient, and peak velocity b. calculated aortic valve area c. degree of bioprosthetic valve regurgitation 16. Assessment for subclinical leaflet thrombosis with multislice computed tomography, or transesophageal echocardiography if GFR <50 mL/min/m2, at 1 to 2 months.
  26. Individual patient level Success all of the following and device success:
  27. No re-hospitalizations or re-interventions for the underlying condition (e.g., HF)
  28. Return to prior living arrangement (or equivalent)
  29. Improvement vs. baseline in symptoms (NYHA Class decrease ≥ 1)
  30. Improvement vs. baseline in functional status (6MWT increase ≥ 50 meters)
  31. Improvement vs. baseline in QoL (KCCQ increase ≥ 10)

Number of Trial Sites: 12

Sample Size: 200 consecutive patients and 200 historical controls, and an additional 100 (up to) patients with bicuspid aortic valve

Patient Population: Patients with severe, symptomatic AS who are determined by the Heart Team to be at low surgical risk (STS score ≤3%).

Conditions
Aortic Stenosis
Being tested
Transfemoral TAVR, SAVR
Medical subject headings
Aortic Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transfemoral TAVRDevice

    Also called Transcatheter aortic valve replacement

  • SAVRDevice

    Also called Surgical Aortic Valve Replacement

Study groups in NCT02628899
Study groupRoleWhat they receive
Prospective TAVR ArmOther200 patients prospectively undergoing transfemoral TAVR
Receives: Device: Transfemoral TAVR
Historical SAVR ControlsOtherHistorical controls will be selected from among patients at the same site who have undergone isolated bioprosthetic SAVR within the previous 36 months. TAVR patients will then be matched to SAVR patients using STS database variables to perform propensity matching, including (but not limited to) age, gender, race, ethnicity, STS score, and valve prosthesis size.
Receives: Device: SAVR
Low-Risk TAVR with Bicuspid Aortic ValveOtherThe third arm of the trial will comprise a registry of TAVR in up to 100 low-risk patients with bicuspid aortic valve. The results from the registry arm will be analyzed independently.
Receives: Device: Transfemoral TAVR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause mortality at 30 days following transfemoral TACR vs. bioprosthetic SAVR

    All-cause mortality at 30 days following transfemoral TACR vs. bioprosthetic SAVR

    Measured: 30 days following transfemoral TAVR vs. bioprosthetic SAVR

  2. Composite of major adverse events at 30 days

    Composite of major adverse events at 30 days

    1. all-cause mortality
    2. stroke
    3. spontaneous myocardial infarction (MI)
    4. reintervention: defined as any cardiac surgery or percutaneous reintervention that repairs, alters, or replaces a previously implanted aortic valve
    5. VARC life-threatening bleeding
    6. Increase in serum creatinine to ≥300% (>3x increase compared to baseline) OR serum creatinine ≥4.0 mg/dL with an acute increase ≥0.5 mg/dL OR new requirement for dialysis
    7. coronary artery obstruction requiring percutaneous or surgical intervention
    8. VARC major vascular complication
    9. cardiac tamponade
    10. cardiac perforation
    11. pericarditis
    12. mediastinitis
    13. hemolysis
    14. infective endocarditis
    15. moderate or severe aortic insufficiency
    16. significant aortic stenosis
    17. permanent pacemaker implantation

    Measured: 30 days

  3. All Cause Mortality

    Measured: 30 days

  4. All Stroke (disabling and non-disabling, ischemic and hemorrhagic

    Measured: 30 Days

  5. Life Threatening and Major Bleeding

    Measured: 30 days

  6. Major Vascular Complications

    Measured: 30 days

  7. Hospitalizations for valve-related symptoms or worsening congestive heart failure

    Measured: 30 days

Secondary outcomes (2)

  1. composite of all-cause mortality, stroke, spontaneous MI, re-intervention

    composite of:

    1. all-cause mortality
    2. stroke
    3. spontaneous MI
    4. re-intervention 2. The occurrence of the individual components of MACCE at 30 days, 6 months, 12 months, and 2, 3, 4, and 5 years. 3. The composite of major adverse device events post-procedure, and at 6 months, 1 year, and 2, 3, 4, 5 years 4. VARC major vascular complications, at 30 days and 1 year 5. VARC life-threatening or disabling bleeding, at 30 days and 1 year 6. Assessment for subclinical leaflet thrombosis with multislice computed tomography, or transesophageal echocardiography if GFR <50 mL/min/m2, at 1 to 2 months.

    Measured: 30 days, 6 months, 12 months, and 2,3,4 and 5 years

  2. VARC - 2 Device Success

    Absence of procedural mortality AND Correct positioning of a single prosthetic heart valve into the proper anatomical location AND Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient<20 mm Hg or peak velocity<3 m/s, AND no moderate or severe prosthetic valve regurgitation)

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2015 (estimated)
  2. Study startJan 2016
  3. Primary completionJan 2023
  4. Study completionJan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
277 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02628899
Sponsor's protocol ID
Low Risk TAVR
Status last verified
May 2024
First submitted
4 Dec 2015
Last updated
16 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Waksman R, Rogers T, Torguson R, Gordon P, Ehsan A, Wilson SR, Goncalves J, Levitt R, Hahn C, Parikh P, Bilfinger T, Butzel D, Buchanan S, Hanna N, Garrett R, Asch F, Weissman G, Ben-Dor I, Shults C, Bastian R, Craig PE, Garcia-Garcia HM, Kolm P, Zou Q, Satler LF, Corso PJ. Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic Severe Aortic Stenosis. J Am Coll Cardiol. 2018 Oct 30;72(18):2095-2105. doi: 10.1016/j.jacc.2018.08.1033. Epub 2018 Aug 28.

    PubMed 30170075

  • Waksman R, Corso PJ, Torguson R, Gordon P, Ehsan A, Wilson SR, Goncalves J, Levitt R, Hahn C, Parikh P, Bilfinger T, Butzel D, Buchanan S, Hanna N, Garrett R, Buchbinder M, Asch F, Weissman G, Ben-Dor I, Shults C, Bastian R, Craig PE, Ali S, Garcia-Garcia HM, Kolm P, Zou Q, Satler LF, Rogers T. TAVR in Low-Risk Patients: 1-Year Results From the LRT Trial. JACC Cardiovasc Interv. 2019 May 27;12(10):901-907. doi: 10.1016/j.jcin.2019.03.002. Epub 2019 Mar 12.

    PubMed 30860059

  • Khan JM, Rogers T, Waksman R, Torguson R, Weissman G, Medvedofsky D, Craig PE, Zhang C, Gordon P, Ehsan A, Wilson SR, Goncalves J, Levitt R, Hahn C, Parikh P, Bilfinger T, Butzel D, Buchanan S, Hanna N, Garrett R, Shults C, Garcia-Garcia HM, Kolm P, Satler LF, Buchbinder M, Ben-Dor I, Asch FM. Hemodynamics and Subclinical Leaflet Thrombosis in Low-Risk Patients Undergoing Transcatheter Aortic Valve Replacement. Circ Cardiovasc Imaging. 2019 Dec;12(12):e009608. doi: 10.1161/CIRCIMAGING.119.009608. Epub 2019 Dec 12.

    PubMed 31826675

  • Rogers T, Torguson R, Bastian R, Corso P, Waksman R. Feasibility of transcatheter aortic valve replacement in low-risk patients with symptomatic severe aortic stenosis: Rationale and design of the Low Risk TAVR (LRT) study. Am Heart J. 2017 Jul;189:103-109. doi: 10.1016/j.ahj.2017.03.008. Epub 2017 Mar 14.

    PubMed 28625366

  • Reddy P, Rodriguez-Weisson FJ, Medranda GA, Merdler I, Cellamare M, Gordon P, Ehsan A, Parikh P, Bilfinger T, Buchbinder M, Roberts D, Hanna N, Ben-Dor I, Satler LF, Garcia-Garcia HM, Asch FM, Weissman G, Sadeghpour A, Schults CC, Waksman R, Rogers T. Impact of Calcified Raphe on TAVR in Bicuspid Patients: Predicting Redo-TAVR Feasibility and Virtual Planning Implications. Circ Cardiovasc Interv. 2025 Jun;18(6):e014802. doi: 10.1161/CIRCINTERVENTIONS.124.014802. Epub 2025 Apr 22.

    PubMed 40260550

  • Bhogal S, Waksman R, Shea C, Zhang C, Gordon P, Ehsan A, Wilson SR, Levitt R, Parikh P, Bilfinger T, Hanna N, Buchbinder M, Asch FM, Weissman G, Ben-Dor I, Shults CC, Ali S, Garcia-Garcia HM, Satler LF, Rogers T. Self-expanding and balloon-expandable valves in low risk TAVR patients. Int J Cardiol. 2024 Jan 15;395:131431. doi: 10.1016/j.ijcard.2023.131431. Epub 2023 Oct 12.

    PubMed 37832606

  • Waksman R, Bhogal S, Gordon P, Ehsan A, Wilson SR, Levitt R, Parikh P, Bilfinger T, Hanna N, Buchbinder M, Asch FM, Kim FY, Weissman G, Ben-Dor I, Shults CC, Ali S, Sutton JA, Shea C, Zhang C, Garcia-Garcia HM, Satler LF, Rogers T. Transcatheter Aortic Valve Replacement and Impact of Subclinical Leaflet Thrombosis in Low-Risk Patients: LRT Trial 4-Year Outcomes. Circ Cardiovasc Interv. 2023 May;16(5):e012655. doi: 10.1161/CIRCINTERVENTIONS.122.012655. Epub 2023 May 16.

    PubMed 37192308

  • Medranda GA, Soria Jimenez CE, Torguson R, Case BC, Forrestal BJ, Ali SW, Shea C, Zhang C, Wang JC, Gordon P, Ehsan A, Wilson SR, Levitt R, Parikh P, Bilfinger T, Hanna N, Buchbinder M, Asch FM, Weissman G, Shults CC, Garcia-Garcia HM, Ben-Dor I, Satler LF, Waksman R, Rogers T. Lifetime management of patients with symptomatic severe aortic stenosis: a computed tomography simulation study. EuroIntervention. 2022 Aug 5;18(5):e407-e416. doi: 10.4244/EIJ-D-21-01091.

    PubMed 35321859

  • Medranda GA, Rogers T, Forrestal BJ, Case BC, Yerasi C, Chezar-Azerrad C, Shults CC, Torguson R, Shea C, Parikh P, Bilfinger T, Cocke T, Brizzio ME, Levitt R, Hahn C, Hanna N, Comas G, Mahoney P, Newton J, Buchbinder M, Zhang C, Craig PE, Weigold WG, Asch FM, Weissman G, Garcia-Garcia HM, Ben-Dor I, Satler LF, Waksman R. Balloon-Expandable Valve Geometry After Transcatheter Aortic Valve Replacement in Low-Risk Patients With Bicuspid Versus Tricuspid Aortic Stenosis. Cardiovasc Revasc Med. 2021 Dec;33:7-12. doi: 10.1016/j.carrev.2021.03.027. Epub 2021 Apr 6.

    PubMed 34078581

  • Waksman R, Torguson R, Medranda GA, Shea C, Zhang C, Gordon P, Ehsan A, Wilson SR, Levitt R, Hahn C, Parikh P, Bilfinger T, Butzel D, Buchanan S, Hanna N, Buchbinder M, Asch F, Weissman G, Ben-Dor I, Shults C, Garcia-Garcia HM, Satler LF, Rogers T. Transcatheter aortic valve replacement in low-risk patients: 2-year results from the LRT trial. Am Heart J. 2021 Jul;237:25-33. doi: 10.1016/j.ahj.2021.03.006. Epub 2021 Mar 10.

    PubMed 33713618

  • Khan JM, Rogers T, Weissman G, Torguson R, Rodriguez-Weisson FJ, Chezar-Azerrad C, Greenspun B, Gupta N, Medvedofsky D, Zhang C, Gordon P, Ehsan A, Wilson SR, Goncalves J, Levitt R, Hahn C, Parikh P, Bilfinger T, Butzel D, Buchanan S, Hanna N, Garrett R, Shults C, Buchbinder M, Garcia-Garcia HM, Kolm P, Satler LF, Hashim H, Ben-Dor I, Asch FM, Waksman R. Anatomical Characteristics Associated With Hypoattenuated Leaflet Thickening in Low-Risk Patients Undergoing Transcatheter Aortic Valve Replacement. Cardiovasc Revasc Med. 2021 Jun;27:1-6. doi: 10.1016/j.carrev.2020.09.034. Epub 2020 Sep 25.

    PubMed 33129688

  • Waksman R, Craig PE, Torguson R, Asch FM, Weissman G, Ruiz D, Gordon P, Ehsan A, Parikh P, Bilfinger T, Levitt R, Hahn C, Roberts D, Ingram M, Hanna N, Comas G, Zhang C, Ben-Dor I, Satler LF, Garcia-Garcia HM, Shults C, Rogers T. Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic Severe Bicuspid Aortic Valve Stenosis. JACC Cardiovasc Interv. 2020 May 11;13(9):1019-1027. doi: 10.1016/j.jcin.2020.02.008. Epub 2020 Feb 24.

    PubMed 32381181

  • Ozaki Y, Garcia-Garcia HM, Rogers T, Torguson R, Craig PE, Hideo-Kajita A, Gordon P, Ehsan A, Parikh P, Bilfinger T, Butzel D, Buchanan S, Levitt R, Hahn C, Buchbinder M, Hanna N, Garrett R, Wilson SR, Goncalves JA, Ali S, Asch FM, Weissman G, Shults C, Ben-Dor I, Satler LF, Waksman R. Coronary Artery Disease Assessed by Computed Tomography-Based Leaman Score in Patients With Low-Risk Transcatheter Aortic Valve Implantation. Am J Cardiol. 2020 Apr 15;125(8):1216-1221. doi: 10.1016/j.amjcard.2020.01.022. Epub 2020 Jan 28.

    PubMed 32087995

Questions about this trial

What is this clinical trial studying?

A study testing Transfemoral TAVR and SAVR in people with Aortic Stenosis, run by Medstar Health Research Institute at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause mortality at 30 days following transfemoral TACR vs. bioprosthetic SAVR (time frame: 30 days following transfemoral TAVR vs. bioprosthetic SAVR). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02628899, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.

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